ArticleTrials2026
AdoHealth e-wellness initiative for adolescent non-communicable disease risk reduction: protocol for a school-based cluster randomised controlled trial in SAS Nagar (Mohali), Punjab, India.
Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundNon-communicable diseases (NCDs) increasingly affect adolescents, particularly in low- and middle-income countries. Seven key lifestyle behaviours, alcohol and tobacco use, consumption of JUNCS foods (junk, ultra-processed, nutritionally inappropriate, caffeinated/coloured/carbonated foods/beverages, sugar-sweetened beverages); physical inactivity; inadequate sleep; excessive screen time; and stress, collectively termed the 'Big-7 Behavioural Risk Determinants', contribute to NCD onset in adolescence and persistence into adulthood.
objectiveTo determine the effectiveness of the AdoHealth e-wellness initiative in reducing the Big-7 Behavioural Risk Determinants among school-going adolescents aged 14-17 years, measured as change from baseline at 6 and 12 months post-intervention compared with control schools.
methodsThis multisite, open-label, superiority cluster randomised controlled trial will include 180 high and senior secondary schools (Classes 9-12, ages 14-17 years; including public and private) in SAS Nagar (Mohali), Punjab, India, randomly assigned in a 1:1 ratio to intervention or control groups, stratified by school location (urban/rural) and school type (government/private). Participants will be recruited by trained field investigators. Eligible participants are students aged 14-17 years enrolled in participating schools, with written parental consent and adolescent assent; students with serious health conditions or planned school transfer will be excluded. The intervention comprises e-modules (10-15 min each) on the Big-7 Behavioural Risk Determinants, delivered via classroom smartboards with facilitator support, over 8 weekly sessions. A pilot phase will be conducted in one school (approximately 100 adolescents) prior to full-scale implementation. Behavioural and biochemical assessments using standardised tools will be conducted at baseline, 6 months, and 12 months post-intervention. Safety monitoring includes adverse event reporting and referral for psychological support as needed. The planned sample size is 18,000 students (9000 per arm across 90 clusters each). The primary endpoint is the change in the 'Big-7 Behavioural Risk Determinants' at 12 months post-intervention, while secondary endpoints include intermediate behavioural changes, biochemical risk markers, and overall well-being. EXPECTED IMPACT: This study aims to evaluate the feasibility and potential effectiveness of school-based e-wellness interventions targeting multiple health behaviours simultaneously. If successful, findings may contribute to early NCD prevention strategies and inform policy development for adolescent health promotion programs in low- and middle-income countries. TRIAL REGISTRATION STATEMENT: Trial registration: Clinical Trials Registry of India (CTRI), CTRI/2025/01/079797. Registered on January 30, 2025. https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=121397&EncHid=98502.11769&modid=1&compid=19 . First participant recruitment commenced on August 16, 2025.
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